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Recruiting NCT06602518

Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients

No phase Interventional Class II Division 2 Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orthodontic Treatment.
Who it may be relevant to
Registry conditions: Class II Division 2 Malocclusion. Basic parameters: 12 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients: A Prospective Clinical Trial

Overview

Aim of the study: is to compare the changes in the sagittal pharyngeal airway dimension (SPAD) and mandibular position before and after the levelling and alignment stage of orthodontic treatment in Class II division 2 patients.

Interventions

  • Procedure Orthodontic Treatment
    All the enrolled patients will undergo conventional fixed appliance therapy by bonding straight wire Roth appliance in the maxillary arch. The bonding procedure will be standardized in all patients and performed by the same operator using light-cured composite. Levelling and alignment will then be started using the following wire sequence: 0.014-in nickel titanium (NiTi), 0.018-in NiTi, 17×25-in Niti, and 19×25-in Niti arch wires. The upper arch will then be stabilized using a 19×25-in stainless

Primary outcome measures

  • Changes in the sagittal pharyngeal airway space (SPAD) [Time frame: 6 months]
Secondary outcome measures (3)
  • Changes in the mandibular position [Time frame: 6 months]
  • Sagittal skeletal measurements [Time frame: 6 months]
  • Vertical skeletal measurements [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Class II/2 subjects as per the British Standard Institute Classification.
  • Age ranging from 12-16 years, with Cervical Vertebral Maturational Index (CVMI) stages 4, and 5.
  • Contact between maxillary and mandibular incisors, with the presence of a deep bite of at least 70%.
  • Full permanent dentition, aside from the third molars

Exclusion criteria

  • Previous orthodontic treatment.
  • Patients with severe transverse problems, pain and/or clicking sound in the temporomandibular joint (TMJ).
  • Patients with craniofacial anomalies or diagnosed syndromes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Alexandria University — Alexandria

Publications

  • Eid FY, Madian AM, Elfouly D. Changes in the sagittal pharyngeal airway dimension following levelling and alignment in class II division 2 patients: a prospective clinical trial. Clin Oral Investig. 2026 Jun 5;30(6):279. doi: 10.1007/s00784-026-06944-2. PMID 42247179

Identifiers

NCT: NCT06602518 · 1/6-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗